Bioequivalence and Bioavailability Forum • for either the test or reference product?

for either the test or reference product? [Outliers]

posted by mittyri – Russia, 2019-02-05 16:58 (1905 d 00:59 ago) – Posting: # 19871
Views: 7,322

Hi Helmut,

maybe I'm only one who is confused with that statement, but:
3. The subject in question should be identified as an outlier for all parameters, for either the test or reference product, upon which the bioequivalence decision is to be based.

Either? Sorry for my poor grammar knowledge but 'either' is a kind of choice, right? So does it mean we need to find out the outliers using the datasets splitted by formulation, not for the ratio T/R? :confused:

—
Kind regards,
Mittyri

Complete thread:

Rules acc. to Health Canada Helmut 2019-02-05 15:04
- Rules acc. to Health Canada ElMaestro 2019-02-05 15:30
  - Rules acc. to Health Canada Helmut 2019-02-05 16:24
    - Rules acc. to Health Canada ElMaestro 2019-02-05 17:33
- Rules acc. to Health Canada Ohlbe 2019-02-05 15:54
  - Rules acc. to Health Canada Helmut 2019-02-05 17:52
- for either the test or reference product?mittyri 2019-02-05 15:58
  - Discordant outliers Helmut 2019-02-05 17:42
- Rules acc. to Health Canada Shuanghe 2019-02-06 11:48
  - Rules acc. to Health Canada ElMaestro 2019-02-06 12:20
    - ESD? mittyri 2019-02-06 14:04
      - ESD? ElMaestro 2019-02-06 18:12
- Rules acc. to Health Canada zizou 2019-02-06 20:52
  - Great post! Helmut 2019-02-07 10:37